| Lifesign Thc, Status Stik Thc, Accusign Stik Thc, Lifesign Marijuana, Accustik Thc | K014066 | FDA 510(k) | Class II | Active |
| Biostrep A-Direct Strep A Antigen Test | K983386 | FDA 510(k) | Class I | Active |
| Biosign Flu A+b | K083746 | FDA 510(k) | Class II | Active |
| Abusign(tm) Thc, Doa-Thc, Accusign(tm) Thc, Doa-Thc, Diosign(tm) Thc, Doa-Thc | K945550 | FDA 510(k) | Class II | Active |
| Biosign Strep A - Direct Strep A Antigen Test | K971349 | FDA 510(k) | Class I | Active |
| Spermcheck Fertility | K100341 | FDA 510(k) | Class II | Active |
| Status™ COVID-19/Flu A&B | K251538 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Accusign Doa3, Doa, Bar/Bzo/Mtd, Biosign Doa3, Biosign Bar/Bzo/Mtd | K991084 | FDA 510(k) | Class II | Active |
| Biosign H. Pylori Wb-New One-Step Anti-H. Pylori Antibody Test | K980798 | FDA 510(k) | Class I | Active |
| Status Hcg Serum/Urine | K020439 | FDA 510(k) | Class II | Active |
| Spermcheck Vasectomy | K073039 | FDA 510(k) | Class II | Active |
| Accusign Doa3, Doa, Coc/Thc/Opi2000 Doa3; Biosign Doa3, Coc/Thc/Opi2000; Status Ds Coc/Thc/Opi2000 | K992422 | FDA 510(k) | Class II | Active |
| Accusign Doa3, Doa3(bzo/Bar/Pcp), Bzo/Bar/Pcp, Biosign Doa3, Doa3(bzo/Bar/Pcp), Bzo/Bar/Pcp | K991076 | FDA 510(k) | Class II | Active |
| Lifesign Dxpress, Model Lsr2000 | K050955 | FDA 510(k) | Class II | Active |
| Accusign Tca, Biosign Tca, Staus Ds Tca | K980249 | FDA 510(k) | Class II | Active |
| Biosign Flu A + B, Status Flu A & B | K132465 | FDA 510(k) | Class II | Active |
| Lifesign Cocaine, Marijuana (thc), Lifesign Doa2 (thc/Coc), Status Stik Thc/Coc, Accusign Stik Thc/Coc, Accustik Thc/Coc | K014067 | FDA 510(k) | Class II | Active |
| Accusign Doa8, Doa8 Panel, Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pcp, Biosign Doa8, Thc/Opi/Coc/Amp/Bzo/Bar/Tca/Pap, Status Ds Do8 | K991078 | FDA 510(k) | Class II | Active |
| Status Ds Oxy | K130650 | FDA 510(k) | Class II | Active |
| Abusign(tm) Opi, Doa-Opi, Accusign(tm) Opi, Doa-Opi, Biosign(tm) Opi, Doa-Opi | K945608 | FDA 510(k) | Class II | Active |
| Accusign Doa 2, Accusign Doa, Accusign Bar/Bzo, Biosign Doa 2, Biosign Bar/Bzo, First Check Panel 2 Bar/Bzo, Status Ds B | K974181 | FDA 510(k) | Class II | Active |
| Biosign Mono-Plus Wb, Biosign Mono Wb, Mono-Plus Wb, Accusign Mono Wb | K961024 | FDA 510(k) | Class II | Active |
| Abusign Doa 2, Doa, Coc/Thc, Doa2, Biosign Doa2, Coc/Thc | K952361 | FDA 510(k) | Class II | Active |
| Modification To: Accusign Rc Doa 10 (met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/Amp | K062575 | FDA 510(k) | Class II | Active |
| Cardiac Status, Lifesign Mi, Vitalsign, Accusign Ck-Mb/Myoglobin | K952360 | FDA 510(k) | Class II | Active |
| Lifesign(tm) 1, Biosign(tm) 1, Lifesign Plus(tm), Lifesign(tm) Hcg | K945514 | FDA 510(k) | Class II | Active |
| Cardiac Status Troponin I | K963513 | FDA 510(k) | Class II | Active |
| Lifesign Doa 4 (thc/Opi/Coc/Met) | K014193 | FDA 510(k) | Class II | Active |
| Lifesign Mi Myoglobin/Troponin I Rapid Test | K022946 | FDA 510(k) | Class II | Active |
| Ovusign - One-Step Home Ovulation Predictor Test | K963693 | FDA 510(k) | Class I | Active |
| Biostrip Hcg I-One Step Pregnancy Test Accustrip Hcg 1-One Step Pregnancy Test Strip | K981444 | FDA 510(k) | Class II | Active |
| Accusign Tca, Biosign Tca, Staus Ds Tca | K981801 | FDA 510(k) | Class II | Active |
| Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status Ds Met | K014192 | FDA 510(k) | U | Active |
| Status First Strep A | K040708 | FDA 510(k) | Class I | Active |
| Status Cup Accusign Cup | K991751 | FDA 510(k) | Class II | Active |
| Accusign Bar, Biosign Bar, Status Bar | K991018 | FDA 510(k) | Class II | Active |
| Accusign Mtd-Rapid One-Step Methadone Assay | K962673 | FDA 510(k) | Class II | Active |
| Lifesign Home Drug Test (ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma | K023837 | FDA 510(k) | Class II | Active |
| Accusign Doa 5 (thc/Opi/Coc/Met Or Amp/Pcp) | K962353 | FDA 510(k) | Class II | Active |
| Biosign Hcg-One Step Pregnancy Test, Accusign Hcg-One Step Pregnancy Test, Lifesign Hcg-One Step Pregnancy Test | K974425 | FDA 510(k) | Class II | Active |
| Accusign, Biosign Pcp | K961266 | FDA 510(k) | U | Active |
| Accusign Amp 300, Biosign Amp 300, Status Ds Amp 300, Syva Rapid Test D.a.u. | K001225 | FDA 510(k) | Class II | Active |
| Accusign Mtd, Biosign Mtd | K991080 | FDA 510(k) | Class II | Active |
| Status Ds Nicotine, Accusign Nicotine, Biosign Nicotine | K062565 | FDA 510(k) | Class I | Active |
| Status Stik, Accusign Stik | K992068 | FDA 510(k) | Class II | Active |
| Abusign(tm) Amp, Doa-Amp, Accusign(tm) Amp-Doa-Amp, Biosign(tm) Amp, Doa-Amp | K945610 | FDA 510(k) | Class II | Active |
| Accusign Bzo-Rapid One-Step Benzodiazepine Assay | K962672 | FDA 510(k) | Class II | Active |
| Lifesign, Care Point, Vitalsign, Accusign | K944325 | FDA 510(k) | Class II | Active |
| Biostrip(r) Hcg-One Step Pregnancy Test | K950307 | FDA 510(k) | Class II | Active |
| Abusign(tm) Coc, Doa-Coc, Accusign(tm) Coc, Doa-Coc, Diosign(tm) Coc, Doa-Coc | K945609 | FDA 510(k) | Class II | Active |